engleski

Change control as a key element of the quality assurance system

Change control represents one of the key elements of the quality assurance system, considering that changes are the main part of quality and business improvement. The purpose of the change control is identification and evidence of changes, evaluation of changes considering the compliance with regulatory requirements, approval of changes and implementation of changes according to requirements of Good Manufacturing Practice (GMP). Thesis explaines EU and US regulatory requirements for Change Control and shows phases of Change Control process: from preliminary activities, change initiation, evaluation, approval, implementation to closure.

Change approval; change closure; change control; quality system

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